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Parenteral preparations are prepared by methods that maintain their sterility, avoiding the introduction of contaminants and microbial growth. Parenteral preparations that are in liquid form require a base to dissolve them. Water for injection is commonly used in parenteral preparations. Any other suitable base may be used provided they are safe at the injection volume administered and do not interfere with the therapeutic efficacy of the drug or the response to tests and assays prescribed in the pharmacopoeia.
Other excipients may be added to increase the stability and usefulness of the preparation. These substances should not cause any adverse effects or toxicity at high concentrations. No coloring agents may be added to parenteral preparations for coloring purposes.
Parenteral preparations packed in multiple-dose containers may contain appropriate antimicrobial preservatives in appropriate concentrations to inhibit microbial growth in the container. Preservative efficacy should be demonstrated before parenteral preparations are manufactured.
When there is potential for oxidative degradation of active ingredients, a suitable antioxidant may be added and/or the vessel may be evacuated or displaced by nitrogen or other suitable inert gas.
Containers: Containers for parenteral preparations should be made from materials that are transparent to permit visual inspection of the contents of the container and that do not adversely affect the quality of the preparation under conditions of storage, handling and use. They may be packed in glass ampoule vials or bottles or other containers such as plastic bottles.
Closure: Vials or bottles are closed with a closure that provides a good seal to prevent the entry of microorganisms and other contaminants and that part or the entire contents of the container can be withdrawn without removing the closure. The material from which the closure is made must be compatible with the preparation and must allow minimal emission of particles from a needle and ensure that the hole is re-exposed when the needle is removed.
Inspection: In accordance with good manufacturing practice, each final container of parenteral preparation must be individually inspected for visible foreign material. If any foreign material is found, the container should be rejected.
Labeling: Containers of parenteral preparations should be labeled in such a way that the area of the container should be exposed for inspection of the contents. The label of any parenteral preparation must contain the name of the preparation, the amount of active ingredient, the storage conditions and the amount of diluent used to obtain the specified concentration of active ingredient.
